ENNOLIFE Comprehensive II Panel

by ProtectLife International Biomedical Inc. Taiwan EUDAMED

Ref 001-3H9CModel HCA-TE-300 EMDN W0101060109

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number++G322G3220013H9C1LUE Basic UDI-DI	Date28 Nov 2025Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name: ENNOLIFE Clinical Chemistry Analyzer (Non-sterile)
Model / Reference: HCA-TE-300, 001-3H9C

Primary DI / UDI-DI: ++G3220013H9C
Basic UDI-DI: ++G322G3220013H9C1LUE
EMDN Code: W0101060109 Multiple parameter blood test

Device Class: Class C
Market of Registration: Romania

Manufacturer details

EUDAMED SRN: TW-MF-000039217
Authorised representative: MedNet EC-REP GmbH DE-AR-000000002

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ENNOLIFE Clinical Chemistry Analyzer (Non-sterile)

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ENNOLIFE Kidney Panel II

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ENNOLIFE HDL Cholesterol Kit (Non-sterile)

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See all devices from ProtectLife International Biomedical Inc. →

Properties & raw data

Show properties, registry sources and raw records

Reagent
Professional Testing
Companion Diagnostics

Other properties (8)

Sterile: No
Human Tissues: No
Animal Tissues: No
Microbial Substances: No
Self Testing: No
Near-Patient Testing: No
Surgical Instrument: No
New Device: No

Sources (1)

EUDAMED 3b850103-fab1-41cc-9fbd-4da2fc520ec0 61 fields · synced 25 Oct 2026